Medical Product Communications That Are Consistent With FDA-Required Labeling

What You Need to Know? 👇

What types of medical products are covered by FDA’s guidance on communications consistent with FDA-required labeling?

The guidance applies to drugs and devices for humans (including biological products) and animal drugs. For 510(k)-cleared and exempt devices, firms should analyze communications using existing 510(k) modification guidance rather than the three-factor framework outlined in this guidance.

How does FDA determine if a product communication is consistent with FDA-required labeling?

FDA uses three factors: (1) whether the communication relates to different indications, patient populations, limitations, or dosing than approved; (2) whether it increases potential harm relative to FDA-required labeling; and (3) whether FDA-required labeling provides adequate directions for safe/effective use under suggested conditions.

Can FDA use consistent communications to establish new intended uses for medical products?

No. FDA does not intend to rely on communications consistent with FDA-required labeling to establish new intended uses different from legally marketed uses. However, these communications must still comply with other applicable requirements and avoid being false or misleading.

What evidence is needed to support promotional communications consistent with FDA labeling?

Communications must be grounded in scientifically appropriate and statistically sound evidence. While the standard doesn’t need to meet approval/clearance requirements, representations must be accurately characterized with material limitations disclosed and not overstate conclusions that can be drawn from supporting studies.

What information must be disclosed in promotional communications to avoid misleading audiences?

Firms should clearly and prominently disclose material aspects of study design, methodology, limitations, and unfavorable findings. Communications should include relevant FDA-required labeling information for context and accurately represent all data without selective presentation of only positive results.

How should firms handle communications about unapproved uses of their approved products?

Communications not consistent with FDA-required labeling fall outside this guidance’s scope. FDA has separate draft guidances addressing unsolicited requests for off-label information and distribution of scientific publications discussing unapproved uses, which describe the Agency’s enforcement priorities and recommended practices.

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What You Need to Do 👇

Recommended Actions

1. Establish a review process involving qualified medical/scientific, legal and regulatory personnel
2. Develop a checklist to verify communications are:
   • Consistent with FDA-required labeling
   • Supported by appropriate scientific evidence
   • Include required contextual information and disclosures
3. Implement procedures to ensure:
   • Accurate representation of study results
   • Clear disclosure of material limitations
   • Inclusion of relevant FDA-required labeling information
4. Create documentation templates that capture:
   • Evidence supporting communications
   • Rationale for consistency with FDA-required labeling
   • Risk assessment regarding potential for harm
5. Maintain records of reviews and approvals of communications
6. Train relevant personnel on requirements and internal procedures
7. Regularly monitor and update communications based on new safety information

Key Considerations

Clinical testing

• Clinical study results must be accurately represented and contextualized
• Material limitations of study design and methodology must be disclosed
• Unfavorable or inconsistent findings should be disclosed
• Data from FDA-required labeling should be included for context when relevant

Labelling

• Communications must be consistent with FDA-required labeling regarding:
  • Indication
  • Patient population
  • Limitations and directions for use
  • Dosing/use regimen and administration
• Information must be truthful and non-misleading
• Material limitations must be clearly and prominently disclosed

Safety

• Communications should not increase potential for harm relative to FDA-required labeling
• Safety information from FDA-required labeling should be included when relevant
• Unfavorable safety findings should be disclosed

Other considerations

• Evidence must be scientifically appropriate and statistically sound
• Claims must be supported by appropriate data
• Material aspects of study design and methodology must be disclosed
• Qualified medical/scientific, legal and regulatory personnel should review communications

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Relevant Guidances 🔗

• Health Care Economic Information Communications to Payors for Medical Devices
• General vs. Specific Indications for Use in Medical Device Substantial Equivalence Determinations
• Device Labeling Requirements and Content for Premarket Approval Applications

Related references and norms 📂

• 21 CFR 201.56: Requirements on content and format of labeling for human prescription drug and biological products
• 21 CFR 202.1: Prescription drug advertisements
• 21 CFR 807.81: When a premarket notification submission is required

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Original guidance

• Medical Product Communications That Are Consistent With FDA-Required Labeling
• HTML / PDF
• Issue date: 2018-06-13
• Last changed date: 2024-11-12
• Status: FINAL
• Official FDA topics: Medical Devices, Drugs, Animal & Veterinary, Biologics, Administrative / Procedural
• ReguVirta ID: 9bbdb45917b13a4eaf93867608efd6aa